Revision History

© 2019 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Geriatric Depression Scale Short Form (GDS SHORT FORM) questionnaire.

CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this questionnaire is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this questionnaire are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.

2 Copyright Status

This instrument is in the public domain. CDISC has included the GDS SHORT FORM in the CDISC library of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the questionnaire. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values (GDS SHORT FORM Annotated CRF.pdf). 

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology.

References for the Geriatric Depression Scale Short Form (GDS SHORT FORM):

• Sheikh JI, Yesavage JA. Geriatric Depression Scale (GDS): recent evidence and development of a shorter version. Clin Gerontol. 1986 June;5(1/2):165-173.
• https://web.stanford.edu/~yesavage/GDS.html
  

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the GDS SHORT FORM are listed below.

The GDS SHORT FORM is a multiple-choice questionnaire that clinicians may use to provide a basic screening measure for depression in older adults. It was modified from the original 30-item Geriatric Depression Scale (GDS) to focus on items with the highest correlation to depressive symptoms in validation studies. It consists of 15 items; each answered "YES" or "NO".  While the CRF has "MOOD SCALE (short form)", the instrument is from the author's website on the Geriatric Depression Scale and the instrument is more commonly known as the GDS SHORT FORM.

1. For the GDS SHORT FORM, QSORRES is populated with the text description (i.e., "YES" or "NO"). There is a scoring guide accompanying the original GDS CRF that determines the value of each answer. A score of "1" is assigned to those values which could contribute to a concern for depression. This has been implemented into the GDS SHORT FORM, with the numeric values represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

2. The time period of evaluation for the GDS SHORT FORM is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the GDS SHORT FORM is the past 1 week.

3. The GDS SHORT FORM instrument includes a total score as explained at the bottom of the CRF that is considered as captured data on the CRF and is not considered as derived in the example below. 

   1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score written on a CRF will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to Y. However, when the subtotal and total scores are received from a central provider or vendor, the value would go into QSORRES and QSDRVFL would be null (See SDTMIG Section 4.1.8.1, Origin Metadata for Variables).

4. Terminology

   1. QSCAT, QSTESTCD and QSTEST values are included in CDISC Controlled Terminology.

   2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the GDS SHORT FORM QS Domain Model

The GDS SHORT FORM example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for a GDS SHORT FORM instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. This result is then transformed into the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.

The table represents the items from the GDS SHORT FORM form.

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

QSTESTCD = "GDS0202" QSTEST = "GDS02-Dropped Activities and Interests"

QSTESTCD = "GDS0203" QSTEST = "GDS02-Life Is Empty"

QSTESTCD = "GDS0204" QSTEST = "GDS02-Bored Often"

QSTESTCD = "GDS0206" QSTEST = "GDS02-Afraid of Something Bad Happening"

QSTESTCD = "GDS0208" QSTEST = "GDS02-Often Feel Helpless"

QSTESTCD = "GDS0209" QSTEST = "GDS02-Prefer to Stay Home"

QSTESTCD = "GDS0210" QSTEST = "GDS02-Memory Problems"

QSTESTCD = "GDS0212" QSTEST = "GDS02-Feel Worthless"

QSTESTCD = "GDS0214" QSTEST = "GDS02-Feel Hopeless"

QSTESTCD = "GDS0215" QSTEST = "GDS02-Most People Better Off Than You"

QSTESTCD = "GDS0201" QSTEST = "GDS02-Satisfied With Life"

QSTESTCD = "GDS0205" QSTEST = "GDS02-Good Spirits Most of Time"

QSTESTCD = "GDS0207" QSTEST = "GDS02-Feel Happy Most of Time"

QSTESTCD = "GDS0211" QSTEST = "GDS02-Wonderful to Be Alive"

QSTESTCD = "GDS0213" QSTEST = "GDS02-Feel Full of Energy"

End of Document